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Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

Primary Purpose

Cesarean Section Complications, Uterine Bleeding

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Niche prevention suture

About this trial

This is an interventional prevention trial for Cesarean Section Complications

Eligibility Criteria

17 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women at first cesarean delivery
Women who consent to the study

Exclusion Criteria:

Women who are having a repeat caesarean section
Refusal to participate in the study
Urgent or emergent cesarean delivery

Sites / Locations

Hadassah Medical OrganizationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

New Closure Technique

Regular closure technique

Arm Description

This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique.

The usual method of closing the surgical incision is to suture the entire wall of the uterus with a stratafix suture without locking the suture.

Outcomes

Primary Outcome Measures

Formation of a uterine niche

Presence of a uterine niche on ultrasound

Secondary Outcome Measures

Duration of surgery

Total duration of surgery

Blood loss over 1000 mL

As assessed by the operating surgeon

Postoperative infection

The number of patients who are diagnosed with postoperative infection including endometritis or wound infection.

Need for repeat laparotomy

The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained.

Formation of a n abscess/hematoma

The number of patients who are diagnosed with a pelvic abscess or hematoma from the time of the cesarean delivery until 6 weeks after the cesarean delivery.

Full Information

NCT ID

NCT04766073

First Posted

February 17, 2021

Last Updated

September 22, 2023

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT04766073

Brief Title

Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

Official Title

Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section. In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cesarean Section Complications, Uterine Bleeding

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

New Closure Technique

Arm Type

Experimental

Arm Description

This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique.

Arm Title

Regular closure technique

Arm Type

No Intervention

Arm Description

The usual method of closing the surgical incision is to suture the entire wall of the uterus with a stratafix suture without locking the suture.

Intervention Type

Procedure

Intervention Name(s)

Niche prevention suture

Intervention Description

This group will have the uterus sutured in two layers using a new technique.

Primary Outcome Measure Information:

Title

Formation of a uterine niche

Description

Presence of a uterine niche on ultrasound

Time Frame

At least 12 weeks after delivery.

Secondary Outcome Measure Information:

Title

Duration of surgery

Description

Total duration of surgery

Time Frame

At surgery

Title

Blood loss over 1000 mL

Description

As assessed by the operating surgeon

Time Frame

At surgery

Title

Postoperative infection

Description

The number of patients who are diagnosed with postoperative infection including endometritis or wound infection.

Time Frame

Up to 6 weeks after intervention

Title

Need for repeat laparotomy

Description

The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained.

Time Frame

Up to 6 weeks after intervention

Title

Formation of a n abscess/hematoma

Description

The number of patients who are diagnosed with a pelvic abscess or hematoma from the time of the cesarean delivery until 6 weeks after the cesarean delivery.

Time Frame

Up to 6 weeks after intervention

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women at first cesarean delivery Women who consent to the study Exclusion Criteria: Women who are having a repeat caesarean section Refusal to participate in the study Urgent or emergent cesarean delivery

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hadas Lemberg, PhD

Phone

+972 2 6777572

lhadas@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hila Hochler, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hadass Lemberg, PhD

Phone

+972 2 6777572

lhadas@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Hila Hochler, MD

First Name & Middle Initial & Last Name & Degree

Simcha Yagel, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

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